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Generated: August 20, 2017

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Zolpidem tartrate - Generic Drug Details

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What are the generic drug sources for zolpidem tartrate and what is the scope of zolpidem tartrate patent protection?

Zolpidem tartrate
is the generic ingredient in seven branded drugs marketed by Torrent Pharms, Dr Reddys Labs Inc, Sandoz, Sanofi Aventis Us, Par Form, Teva, Biovail Labs Intl, Aurobindo Pharma, Allied Pharma Inc, Mylan Pharms Inc, Vintage, Sandoz Inc, Wockhardt, Purdue Pharma, Hikma, Synthon Pharms, Anchen Pharms, Actavis Labs Fl Inc, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Vivimed Labs, Apotex Inc, Lupin Ltd, Sun Pharma Global, Watson Labs, Mylan, Actavis Elizabeth, Invagen Pharms, Dr Reddys Labs Ltd, Cipla Ltd, Sun Pharm Inds, Yung Shin Pharm, Amherst Pharms Llc, Mylan Speciality Lp, and Novel Labs Inc, and is included in thirty-nine NDAs. There are eleven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has two hundred and twenty-four patent family members in thirty-six countries.

There are thirty-one drug master file entries for zolpidem tartrate. Sixty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: zolpidem tartrate

Tradenames:7
Patents:11
Applicants:35
NDAs:39
Drug Master File Entries: see list31
Suppliers / Packagers: see list65
Bulk Api Vendors: see list30
Clinical Trials: see list225
Patent Applications: see list930
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:zolpidem tartrate at DailyMed

Pharmacology for Ingredient: zolpidem tartrate

Tentative approvals for ZOLPIDEM TARTRATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe5MGTABLET;ORAL
► Subscribe► Subscribe10MGTABLET;ORAL
► Subscribe► Subscribe10MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL076578-002Apr 23, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;SUBLINGUAL202657-002Aug 8, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo► Subscribe► Subscribe ► Subscribe
Par Form
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;SUBLINGUAL201509-002Aug 1, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL077388-002Jul 30, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-001Dec 16, 1992► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-002Dec 16, 1992► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: zolpidem tartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain► Subscribe
7,910,132Pharmaceutical composition for the treatment of acute disorders► Subscribe
8,097,431Methods and compositions for detecting steroids► Subscribe
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system► Subscribe
9,078,816Buccal, polar and non-polar spray containing ondansetron► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: zolpidem tartrate

Country Document Number Estimated Expiration
Czech Republic306387► Subscribe
Hungary230468► Subscribe
Australia2005215782► Subscribe
Japan2007507509► Subscribe
New Zealand510284► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ZOLPIDEM TARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00004Denmark► SubscribePRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
4Finland► Subscribe
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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Serving 500+ biopharmaceutical companies globally:

Dow
Cantor Fitzgerald
Harvard Business School
Citi
Mallinckrodt
McKesson
US Department of Justice
Accenture
Daiichi Sankyo
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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